MalfunctionDTY
TERUMO CDI 101 MONITOR
Received Mar 4, 2011 · Event occurred Jan 20, 2011
Report 1828100-2011-00471 · MDR key 2030820
Device
Product problems
- Device Displays Incorrect Message
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.
Description of Event or Problem
DURING PRIMING OF THE DEVICE IN PREPARATION FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE UNIT FAILED TO READ PARAMETERS AND THAT A "COLOR CHIP" ERROR MESSAGE OCCURRED. A VERY TIGHT INTERFACE CABLE CONNECTION WAS ALSO NOTED. THE DEVICE WAS NOT CHANGED OUT FOR THE PROCEDURE. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PT AS A RESULT OF THIS EVENT.